Obsessive-Compulsive DisorderNCT01809990
Internet-delivered CBT for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study
A study testing Internet-delivered Cognitive Behavior Therapy in people with Obsessive-Compulsive Disorder, run by Eva Serlachius at 1 site in Sweden.
Trial summary
The main goal of this trial is to study the feasibility and effectiveness of internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Internet-delivered Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a primary diagnosis of OCD as defined by DSM-IV TR
- a total score of above 15 on the CY-BOCS
- age between 12 and 17 years
- ability to read and write Swedish
- daily access to the internet
- a parent that is able to co-participate in the treatment
- Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
- signed informed consent
Who cannot join
- diagnosed autism spectrum disorder, psychosis or bipolar disorder
- suicidal ideation
- ongoing substance dependence
- subject not able to read or understand the basics of the ICBT self-help material
- completed CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
- ongoing psychological treatment for OCD or another anxiety disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study
The main goal of this trial is to study the feasibility and effectiveness of internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Internet-delivered Cognitive Behavior Therapy
- Keywords
- cognitive behavior therapy, pediatric obsessive-compulsive disorder, internet-delivered cognitive behavior therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive Behavior TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| internet-delivered cognitive behavior therapy | Experimental | Participants will be assigned to a 12 weeks internet-delivered cognitive behavior therapy program including therapist contact via an internet platform and telephone. Receives: Behavioral: Internet-delivered Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 6 months after treatment.
Measured: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Secondary outcomes (5)
Spence Child Anxiety Scale - Child and Parent version
Spence Child Anxiety Scale - Child and Parent version (SCAS/P, Spence, 1998) will be used as a child and parent self-report measure of anxiety related psychopathology.
Measured: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Depression Inventory
Symptom severity of depression in the adolescent will be assessed with Child Depression Inventory (CDI, Kovacs, 1985).
Measured: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Strengths Difficulties Questionnaire
Strengths Difficulties Questionnaire (SDQ, Goodman, 1997) is a widely used self- and parent-report behavioral screening questionnaire with six subscales: emotional problems, conduct problems, hyperactivity-inattention, peer problems, prosocial behavior
Measured: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Children's Obsessional Compulsive Inventory Revised
The Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003) is a self- and parent-report measure of pediatric OCD symptom severity.
Measured: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Obsessive-Compulsive Impact Scale - Revised
Child Obsessive-Compulsive Impact Scale - Revised (COIS-R, Piacentini, Peris, Bergman, Chang, \& Jaffer, 2007) is a self- and parent-report scale of OCD symptom impact on everyday life.
Measured: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Serlachius
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Sponsor-investigator, Eva Serlachius, Karolinska Institutet
- Investigators
- Eva Serlachius, PhD, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809990
- Sponsor's protocol ID
- BIPOCD1
- Status last verified
- Jun 2014
- First submitted
- 17 Feb 2013
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Flessner CA, Sapyta J, Garcia A, Freeman JB, Franklin ME, Foa E, March J. Examining the Psychometric Properties of the Family Accommodation Scale-Parent-Report (FAS-PR). J Psychopathol Behav Assess. 2009 Mar;31(1):38-46. doi: 10.1007/s10862-010-9196-3.
PubMed 21743772Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.
PubMed 12501574Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
PubMed 9255702Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
PubMed 4089116Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Piacentini J, Peris TS, Bergman RL, Chang S, Jaffer M. Functional impairment in childhood OCD: development and psychometrics properties of the Child Obsessive-Compulsive Impact Scale-Revised (COIS-R). J Clin Child Adolesc Psychol. 2007 Oct-Dec;36(4):645-53. doi: 10.1080/15374410701662790.
PubMed 18088221Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.
PubMed 9183141Shafran R, Frampton I, Heyman I, Reynolds M, Teachman B, Rachman S. The preliminary development of a new self-report measure for OCD in young people. J Adolesc. 2003 Feb;26(1):137-42. doi: 10.1016/s0140-1971(02)00083-0.
PubMed 12550826Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. doi: 10.1016/s0005-7967(98)00034-5.
PubMed 9648330Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Lenhard F, Vigerland S, Andersson E, Ruck C, Mataix-Cols D, Thulin U, Ljotsson B, Serlachius E. Internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder: an open trial. PLoS One. 2014 Jun 20;9(6):e100773. doi: 10.1371/journal.pone.0100773. eCollection 2014.
PubMed 24949622
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study
- ClinicalTrials.gov ID
- NCT01809990
- Acronym / sponsor ID
- BIPOCD1
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- cognitive behavior therapy, pediatric obsessive-compulsive disorder, internet-delivered cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eva SerlachiusUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this trial is to study the feasibility and effectiveness of internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| internet-delivered cognitive behavior therapy | Experimental | Behavioral: Internet-delivered Cognitive Behavior TherapyParticipants will be assigned to a 12 weeks internet-delivered cognitive behavior therapy program including therapist contact via an internet platform and telephone. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- a primary diagnosis of OCD as defined by DSM-IV TR
- a total score of above 15 on the CY-BOCS
- age between 12 and 17 years
- ability to read and write Swedish
- daily access to the internet
Key exclusion criteria (6 listed)
- diagnosed autism spectrum disorder, psychosis or bipolar disorder
- suicidal ideation
- ongoing substance dependence
- subject not able to read or understand the basics of the ICBT self-help material
- completed CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered Cognitive Behavior Therapy | Behavioural | internet-delivered cognitive behavior therapy |
Primary outcome
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
Time frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 6 months after treatment.
5 secondary outcomes
Spence Child Anxiety Scale - Child and Parent version
Time frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Depression Inventory
Time frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Strengths Difficulties Questionnaire
Time frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Children's Obsessional Compulsive Inventory Revised
Time frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Obsessive-Compulsive Impact Scale - Revised
Time frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Background: PubMed 21743772Flessner CA, Sapyta J, Garcia A, Freeman JB, Franklin ME, Foa E, March J. Examining the Psychometric Properties of the Family Accommodation Scale-Parent-Report (FAS-PR). J Psychopathol Behav Assess. 2009 Mar;31(1):38-46. doi: 10.1007/s10862-010-9196-3.
- Background: PubMed 12501574Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.
- Background: PubMed 9255702Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
- Background: PubMed 4089116Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 18088221Piacentini J, Peris TS, Bergman RL, Chang S, Jaffer M. Functional impairment in childhood OCD: development and psychometrics properties of the Child Obsessive-Compulsive Impact Scale-Revised (COIS-R). J Clin Child Adolesc Psychol. 2007 Oct-Dec;36(4):645-53. doi: 10.1080/15374410701662790.
- Background: PubMed 9183141Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.
- Background: PubMed 12550826Shafran R, Frampton I, Heyman I, Reynolds M, Teachman B, Rachman S. The preliminary development of a new self-report measure for OCD in young people. J Adolesc. 2003 Feb;26(1):137-42. doi: 10.1016/s0140-1971(02)00083-0.
- Background: PubMed 9648330Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. doi: 10.1016/s0005-7967(98)00034-5.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Derived from this study: PubMed 24949622Lenhard F, Vigerland S, Andersson E, Ruck C, Mataix-Cols D, Thulin U, Ljotsson B, Serlachius E. Internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder: an open trial. PLoS One. 2014 Jun 20;9(6):e100773. doi: 10.1371/journal.pone.0100773. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Serlachius, PhD, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cognitive Behavior Therapy in people with Obsessive-Compulsive Disorder, run by Eva Serlachius at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS (time frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809990, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.